penumbrainc - Clinical Data Manager (Temporary Position, 20 hours/week)
Requirements
• Bachelor's degree with 5+ years in a medical device, pharmaceutical company, or similar environment (e.g., CRO); or an equivalent combination of education and experience • Master’s degree with 3+ years of clinical research, pharmaceutical company preferred • Thorough knowledge of effective clinical data management practices; CCDM certified professional a plus • Must have strong experience with systems used for electronic capture of clinical trial data (e.g., iMedidata Rave, InForm, eClinicalOS, RedCap) • This position must have experience working on regulatory trials within the medical device and/or pharmaceutical industry • Position requires technical, organizational, analytical, and strong communication skills • Knowledge of regulatory guidelines pertaining to data quality and data management • Proven experience and in-depth understanding of all aspects of Data Management • Ability to effectively manage change and multiple priorities • Ability to operate independently and achieve results; ability to effectively deal with employees and business contacts and conveys a positive service-oriented attitude • Knowledge of continuous improvement, project management, change management, and risk management • Medical device, pharmaceutical, biotech, or other regulated industry experience required • Proficiency with MS Word, Excel, and PowerPoint • Working Conditions • General office environment • Willingness and ability to work on site. • May have business travel from 0% - 5% to conferences and/or other Penumbra affiliated facilities. • Potential exposure to blood-borne pathogens • Requires some lifting and moving of up to 25 pounds • Must be able to move between buildings and floors. • Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day. • Must be able to read, prepare emails, and produce documents and spreadsheets. • Must be able to move within the office and access file cabinets or supplies, as needed. • Must be able to communicate and exchange accurate information with employees at all levels on a daily basis. Must be able to communicate and exchange accurate information with employees at all levels on a daily basis. • Base Pay Range Per Hour: $50.00 - $80.00 • Individual compensation will vary based on factors such as qualifications, skill level, competencies, and work location. • Working Conditions
Responsibilities
• Independently lead and/or perform all data management activities within an assigned study (e.g., study startup, study conduct, study closeout, and reporting). * • Serve as the data management SME on multidisciplinary project teams providing specific expertise on timeline development, identification of data management deliverables and resource requirements. * • Participate in the creation, review, and maintenance of project timelines and monitor progress of data management activities. * • Provide oversight for Data Management CRO and other vendors to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, and other relevant guidelines. • Ensure Data Management documentation is filed/archived according to applicable Penumbra and regulatory requirements. * • Interact with data management, biostatistics, Clinical Affairs and Medical Affairs team to ensure integrity and quality of data. * • Contribute ideas to the development of the department, identifying areas for improvement (e.g., SOPs, processes) • Participates in audits and inspections. * • Attend Investigator Meetings when requested to provide training on CRF data completion. • Responsible for creation of training materials and training of the CRAs to ensure consistency of data entry at the sites. * • Provide DM departmental training and to other teams, as needed. • Utilizes reports to track study progress and ensure timeliness and quality expectations are met. • Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. * • Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. * • Ensure other members of the department follow the QMS, regulations, standards, and procedures. * • Perform other work-related duties as assigned. • Indicates an essential function of the role
Benefits
• A collaborative teamwork environment where learning is constant, and performance is rewarded.
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